Deriving Validation
Acceptance Criteria

By William Brown, Contibuting Writer

Where do the acceptance criteria for process validations come from? Even though this is one of the most important aspects of the validation process, the answer to this question is often shrouded in mystery.

Devine Guidance

What Part of Process Validation is Not
Being Understood?

By Dr. Christopher Joseph Devine,
Devine Guidance International

Process Validation should be considered one of the basic tenants associated with the manufacturing of finished medical devices that are safe and effective in their intended use. However, what happens when a device establishment fails to implement an effective program for process validation?

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